Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
FDA Recall Z-0535-2008 · Posted 2007-12-22
Recalling FirmAmbu Incorporated
Recall StatusTerminated
Product CodeBYE
Date Initiated2007-08-21
Date Terminated2008-06-16
Product Quantity197 total
Reason for Recall
Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
Firm Action
Ambu notified consignees with a letter dated 08/21/07 and flagged as Trouble Shooting Guide. The letter advised that some valves do not hold the set PEEP level under certain conditions and consignees were further advised to consider the guideline as an addendum to existing directions for use. Consignees were instructed to return (to Ambu) for replacement the identified lots listed in the notification and confirm receipt of the advisory by e-m or fax.
Ambu subsequently identified additional lots of valves and replacement valve parts for recall and notified all consignees by "Urgent Device Recall" letter dated 11/29/07. The letter advised healthcare practitioners of the impact on patient treatment that may result in less than effective treatment. Consignees were further advised to cease use of the device and return for replacement.
Root Cause
Process design
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.